What is CADIFA Filing?
Posted on04 Jul 2024
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CADIFA (Carta de Adequação de Dossiê de Insumo Farmacêutico Ativo) is a letter issued by ANVISA (Agência Nacional de Vigilância Sanitária) that certifies the approval... Read More
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Is Market Access is Only About Pricing?
It is a common misconception that market access is solely focused on determining and negotiating the price of a drug. Many assume that once a... Read More
What are the differences between pharma market access and pharma forecasting?
Pharma market access and forecasting are two distinct but interconnected areas within the pharmaceutical industry. Pharma market access involves ensuring that patients can obtain the... Read More
Regulatory CMC Writing – Self Assessment Test
Posted on21 May 2024
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Here is Regulatory CMC Writing self assessment test. Check your fundamental competency with free Regulatory Writing Self Assessment Test. Difficulty Level : Easy Regulatory Writing... Read More
What is ISO 10993?
Posted on16 May 2024
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ISO 10993 is a series of international standards for evaluating the biological safety of medical devices. These standards are developed by the International Organization for... Read More
What is Pharma Market Access?
Posted on15 May 2024
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Pharma market access refers to the process of ensuring that pharmaceutical products are available and accessible to patients who need them. It encompasses a range... Read More
Protected: Demo Access – Africa Regulatory Affairs
Posted on15 May 2024
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There is no excerpt because this is a protected post.
Difference between Validation and Calibration
Posted on15 May 2024
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Validation and calibration are both crucial processes in various fields, particularly in science, engineering, and manufacturing. While they are related concepts, they serve distinct purposes.... Read More
How to become a medical sales representative?
Becoming a medical sales representative typically requires a combination of education, relevant experience, and specific skills. Here’s a general roadmap: Academics / Educational Background While... Read More
Role of CMC in Drug Development Process
Chemistry, Manufacturing, and Controls (CMC) constitutes that part of pharmaceutical development that deals with the nature of the drug substance and drug product, the manner... Read More
What are notarized documents?
Drug Department asking for documents to be notarizerd. What does it means? How documents should be notarized? — Notary means a person authorized to perform... Read More
Case Study: J&J acquisition of ORS L
Posted on05 Mar 2024
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The world’s sixth largest consumer health and pharma giant Johnson & Johnson (J&J) has emerged as a front-runner to acquire electrolyte energy drink business of... Read More